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LUNA18 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Chugai Pharmaceutical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years at time of signing informed consent form
Patients with a histologically or cytologically proven diagnosis of a locally advanced, recurrent, or metastatic incurable solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new drug, LUNA18, in patients with solid tumors.

Who is the study for?
Adults over 18 with advanced solid tumors not responding to standard treatments can join. They must be relatively healthy (ECOG status of 0 or 1) and have RAS mutation-positive tumors that are measurable. Those with serious heart conditions, uncontrolled diseases, lung complications like ILD, brain cancer, or active brain metastases needing treatment cannot participate.Check my eligibility
What is being tested?
The study is testing LUNA18's safety and effectiveness alone or with other cancer drugs in patients with advanced solid tumors. It's a Phase 1 trial where doses increase gradually to find the right balance between safety and potential benefits.See study design
What are the potential side effects?
Possible side effects include reactions related to Cetuximab such as skin rash, low magnesium levels, infusion-related symptoms; for LUNA18 specific side effects aren't listed but may align with typical cancer drug risks like nausea, fatigue, blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My cancer is advanced, cannot be cured with surgery, and standard treatments haven't worked or I can't tolerate them.
Select...
I am fully active or can carry out light work.
Select...
My solid tumor is positive for RAS alterations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration versus time curve (AUC) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Maximum plasma concentration (Cmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part B]
+5 more
Secondary outcome measures
Anti-drug antibody to LUNA18[Part A, AA, B, C, D and E]
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part A, AA, C, D, E]
Plasma concentrations of LUNA18 [Part B, C and E]
+2 more

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Non-cardiac chest pain
18%
Alkaline phosphatase increased
18%
Aspartate aminotransferase increased
18%
Insomnia
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Dizziness
10%
Arthralgia
10%
Edema limbs
8%
Anxiety
8%
Oral dysesthesia
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Tracheostomy site bleeding
3%
Vertigo
3%
Alopecia
3%
Oral pain
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose finding part (Part D)Experimental Treatment2 Interventions
Patients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses
Group II: Dose escalation part (Part A)Experimental Treatment1 Intervention
Patients will receive LUNA18 capsule(s) at escalated doses
Group III: Cohort expansion part (Part E)Experimental Treatment2 Interventions
Patients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose
Group IV: Cohort expansion part (Part C)Experimental Treatment1 Intervention
Patients will receive LUNA18 capsule(s) at the recommended dose
Group V: Biomarker part (Part B)Experimental Treatment1 Intervention
Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A
Group VI: Backfill part (Part AA)Experimental Treatment1 Intervention
Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Chugai PharmaceuticalLead Sponsor
95 Previous Clinical Trials
21,509 Total Patients Enrolled
Sponsor Chugai Pharmaceutical Co. LtdStudy Directorclinical-trials@chugai-pharm.co.jp
9 Previous Clinical Trials
675 Total Patients Enrolled

Media Library

LUNA18 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05012618 — Phase 1
Solid Tumors Research Study Groups: Backfill part (Part AA), Dose escalation part (Part A), Biomarker part (Part B), Cohort expansion part (Part E), Cohort expansion part (Part C), Dose finding part (Part D)
Solid Tumors Clinical Trial 2023: LUNA18 Highlights & Side Effects. Trial Name: NCT05012618 — Phase 1
LUNA18 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05012618 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has LUNA18 received regulatory approval from the FDA?

"LUNA18's safety is estimated to be a 1. This is due to it only being in Phase 1, meaning that there is very limited data supporting both its efficacy and safety."

Answered by AI

Could you elaborate on the number of individuals who have chosen to participate in this experiment?

"The answer is affirmative. The clinical trial in question, which was announced on October 8th 2021, has not reached its full patient quota yet and is still looking for individuals to participate. A total of 195 people are needed at 2 different locations."

Answered by AI

Are there any vacancies in this research project for new participants?

"That is correct, the clinical trial detailed on clinicaltrials.gov is actively recruiting patients. The posting date was October 8th 2021 and the most recent edit was made on October 17th 2022. There are currently 2 locations enrolling a total of 195 participants."

Answered by AI

What are we hoping to achieve by conducting this experiment?

"The primary objective of this trial is to measure plasma concentrations of LUNA18. The secondary objectives include measuring the phosphorylation level of ERK protein in tumor tissues and assessing the preliminary anti-tumor activity of LUNA18."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
2021. "A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05012618.
~52 spots leftby Mar 2025
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